Roche at centre of avian influenza storm

In the midst of fears of an avian influenza epidemic and arguments over World Trade Organisation (WTO) rules for patents, Roche has announced that it is to donate 2,400 packs of its anti-influenza drug Tamiflu to Romania and sell 20,000 packs of to Turkey, having already promised to donate three million packs to the WHO.

The Swiss group has come under pressure in recent weeks amid booming demand from public health authorities and private consumers for Tamiflu; its basic compound, osletamivir, is regarded as a main line of defence against influenza threat.

The company says that it is increasing production of Tamiflu in the face of the potential epidemic, but while it has agreed to outsource some stages of production, it is refusing to relinquish its patents. However, its monopoly over production and marketing of the drug, combined with its lack of production capacity amid mounting demand, has drawn comparisons with a row over the availability of anti-AIDS drugs in poor countries. That situation led to new rules in the WTO to allow governments to cope with a public health emergency, and in 2001 a loophole in international intellectual property agreement was opened up to give countries 'compulsory licensing' rights for medicines in order to protect public health. Under the declaration, governments can waive the patent rights of a private company and grant a compulsory production licence to a domestic company, thus allowing generic copies of a drug to be made, although the patent holding company will be due 'adequate remuneration' if such a situation arises.

'Each member has the right to grant compulsory licences and the freedom to determine the grounds upon which such licences are granted,' according to a declaration adopted by ministers in Doha, Qatar.

However, any country seeking to produce an anti-flu drug must first try to reach an agreement with the licence holder, and Roche claims to have currently received only one request to produce Tamiflu, which has come from Taiwan.Indian drugs manufacturer Cipla, which is also involved in the production of cheaper generic copies of HIV/AIDS drugs under the WTO rules, has reportedly shown an interest in pro-ducing copies of anti-flu drugs, but, according to Roche, has not made any official inquiries.

UN Secretary General Kofi Annan has called for patent issues to be resolved, asking pharmaceutical companies to be 'helpful, making sure that we do not allow intellectual property to get in the way of access of the poor to medication'.

WHO pandemic alert chief Mike Ryan has said of the situation: 'clearly we don't have enough anti-virals in the world to deal with all of the potential cases that may occur in a pandemic. The WHO believes that there is a public health need to overcome all obstacles in the trade and licensing area.' He added that the UN health agency was working with 'that manufacturer' on scaling up production and licensing issues.

The virus has claimed more than 60 lives in Asia since 2003, and fears are rife that it could mutate into a more deadly form for humans.